Description

Docetaxel Impurity 24 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Docetaxel drug substance and finished products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology sectors who require reliable standards for method development, validation, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for impurity profiling and identification.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Docetaxel.
• Used in quality control (QC) and quality assurance (QA) laboratories to monitor batch-to-batch consistency.
• Essential for regulatory compliance and submission (e.g., ICH guidelines Q3A, Q3B) requiring impurity characterization.
• Supports stability studies to track impurity formation in drug products over time.
• Valuable for research and development into the synthesis, degradation pathways, and metabolism of Docetaxel.

Basic Information

Product Name	Docetaxel Impurity 24
CAS No.	1217248-58-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docetaxel Related Compound 24; Docetaxel EP Impurity 24; Docetaxel USP Impurity 24; 7-Epi-10-oxo-docetaxel; 10-Oxo-7-epi-docetaxel; (2R,3S)-3-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoic Acid (1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(Acetyloxy)-15-{[(2R,3S)-3-{[(tert-Butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1,9,12-trihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl Ester
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity 24 is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including chromatographic purity and structural confirmation, to guarantee identity, potency, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods. Our quality commitment aligns with the standards expected for materials used in GMP environments and regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry place after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.